Group Information: A list of the study investigators is available in eAppendix 1 of Supplement 1.
Study concept and design: Gerding, Lee, Ramos, Chen, Villano.
Acquisition, analysis, or interpretation of data: Gerding, Meyer, Lee, Cohen, Murthy, Poirier, Schooneveld, Pardi, Barron, Chen, Villano.
Drafting of the manuscript: Gerding, Lee, Ramos, Barron, Chen, Villano.
Critical revision of the manuscript for important intellectual content: Gerding, Meyer, Lee, Cohen, Murthy, Poirier, Schooneveld, Pardi, Barron, Chen, Villano.
Statistical analysis: Gerding, Chen, Villano.
Obtained funding: Villano.
Administrative, technical, or material support: Schooneveld, Pardi.
Study supervision: Ramos, Villano.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Gerding reports holding patents for the prevention of CDI licensed to ViroPharma/Shire; consultancy for ViroPharma/Shire, MedImmune, Sanofi Pasteur, Cubist, Optimer, DaVolterra, and Pfizer; and membership in the advisory boards of Merck, Rebiotix, Summit, and Actelion. Dr Lee reports participation in clinical trials for ViroPharma, Actelion, Cubist, and Merck and membership in the advisory boards for Rebiotix, Cubist, and Merck. Dr Cohen reports membership in the advisory boards of Merck and ViroPharma/Shire and clinical trial participation with ViroPharma/Shire, Cubist, Actelion, and Merck. Dr Poirier reports clinical trial participation with GlaxoSmithKline, Merck, Cubist, Bayer, Actelion, and ViroPharma. Dr Van Schooneveld reports research support from ViroPharma and Cubist and speaker fees from Thermo-Fischer. Dr Pardi reports consultancy for Seres Health and having served on advisory boards for Cubist and Optimer. Dr Barron reports membership in advisory boards for Astellas Pharma US and current clinical trial participation with Astellas Pharma US, ViroPharma/Shire, GlaxoSmithKline, Actelion T2 Biosystems, and Merck. Dr Chen reports Shire stock/options. Drs Chen and Villano were full-time employees of ViroPharma/Shire during the conduct of this study. No other disclosures were reported.
Funding/Support: This study was sponsored by ViroPharma Incorporated, which is now part of the Shire group of companies.
Role of the Funder/Sponsor: Viropharma/Shire employees were involved in the study design and management, analysis, and interpretation of the data. Viropharma/Shire employees or former employees are authors of this article and were involved in the drafting of the manuscript and approval to submit the manuscript for publication.
Previous Presentation: This study was previously presented in abstract form (abstract LB-7) at IDWeek 2013; San Francisco, California; October 5, 2013.
Additional Contributions: The data monitoring committee for this study comprised Aruna Subramanian, MD, Stanford University School of Medicine, Stanford, California; Nina Singh, MD, University of Pittsburgh, Pittsburgh, Pennsylvania; and George Alangaden, MD, Henry Ford Hospital, Detroit, Michigan. Medical writing support was provided by David Lickorish, PhD, Excel Scientific Solutions, funded by Shire.